BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATION

GUDID 93700386954873

TORNIER

Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 93700386954873
• NIH Device Record Key: ff8e56e7-d396-4dc9-aaa3-f2d161dd3914
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATION
• Version Model Number: MWJ001
• Company DUNS: 260324876
• Company Name: TORNIER
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com
• Phone: +330476613500
• Email: order@tornier.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	93700386954873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143374

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

[93700386954873]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-11

On-Brand Devices [BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATION]

• 93700386998983: MWJ021
• 93700386998976: MWJ004
• 93700386998969: MWJ003
• 93700386998952: MWJ001
• 93700386954903: MWJ012
• 93700386954897: MWJ010
• 93700386954880: MWJ002
• 93700386954873: MWJ001
• 03700386955662: MWJ013
• 03700386955679: REVERSED 3D GLENOID MODEL
• 03700386955655: MWJ004
• 03700386955648: MWJ003
• 03700386925726: MWJ021